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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC

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W. L. GORE & ASSOCIATES, INC. GORE DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 06/05/2020
Event Type  Injury  
Manufacturer Narrative

Product identification records for the alleged gore device were not provided. Therefore, a review of the manufacturing records could not be performed. It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence. " the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ".

 
Event Description

It was reported to gore that the patient underwent laparoscopic ventral incisional hernia repair on (b)(6) 2014 whereby a gore® dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2020, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: infected mesh, abscess, mesh removal, drainage, and pain and suffering. Additional event specific information was not provided.

 
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Brand NameGORE DUALMESH BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
megan reigh
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12000967
MDR Text Key256270040
Report Number3003910212-2021-01230
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/15/2021 Patient Sequence Number: 1
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